Table of Contents 目录 1 Introduction 简介 9 2 General Concepts 一般概念 9 2 .1 Size Exclusion 尺寸排除 10 2 .2 Other Retention Mechanisms 其他滞留方法 11 2 .3 Virus Retention Probability of Reduction Factor (RF) 病毒滞留可能性的减少因素（RF） 11 2 .4 Virus Size/Retention Rating病毒大小/滞留量 11 2 .5 Protein Size/Sieving/Passage Rating 蛋白质大小/过滤/通过量 11 3 Virus Filter Selection and Characterization 病毒选择和特性 12 3 .1 Filter Construction 过滤器结构 12 3 .2 Filter System Configurations 过滤系统配置 12 3 .3 Particulates and Extractables 微粒和萃取物 13 3 .4 Filter Compatibility 过滤兼容性 14 3 .5 Protein Recovery (Adsorption/Retention/Biocompatibility) 蛋白质恢复（吸附/滞留/生物兼容性） 15 3 .6 Thermal Stress Resistance 热应力阻止 16 3 .7 Hydraulic Stress Resistance 水应力阻力 16 3 .8 Toxicity Testing 毒性试验 16 3 .9 Viral/Phage Challenge Testing 病毒/噬菌体挑战试验 16 3 .1 0 Cleaning/Sanitization/Sterilization 清理/消毒/灭菌 17 4 Physical and Mechanical Characteristics 物理力学特性 17 4 .1 Filtration Rate and Clogging (Throughput) 过滤速度及堵塞（通过量） 17 4 .2 Fluid/Piping 液体/管道 17 4 .3 Fluid/Filter 液体/过滤器 17 4 .4 Physical and Structural Limitations 物理结构限制 17 4 .5 Miscellaneous 多样性 17 5 Virus Filter Validation/Evaluation Studies 病毒过滤器/评估研究 17 5 .1 Filter Properties 过滤器属性 18 5 .2 Test Virus 测试病毒 18 5 .2 .1 Virus Selection 病毒选择 18 5 .2 .2 Virus Stock Preparation and Maintenance 病毒库制备和维护 19 5 .2 .3 Virus Spike 病毒峰值 20 5 .3 Scaled-down Models 缩小模型 21 5 .4 Operating Conditions for Validation, Revalidation, and Number of Runs 验证，再验证的运行条件和运行次数 21 5 .5 Raw Materials and Equipment 原材料和设备 22 5 .5 .1 Virus Filtration Devices and Configurations 病...
